Consulting on ISO 13485 implementation

The safe use of a medical device depends on a good design and development project, but also on the implementation of a set of other activities provided by a “Quality Management System”.

 

It is for this reason that the European Commission has adopted the standard EN ISO 13585 – Quality management systems – Requirements for regulatory purposes, as a harmonized standard to meet legal requirements of regulation (EU) 2017/745 and regulation (EU) 2017/745. As a harmonized standard, the certification of the Quality Management System by EN ISO 13485 successfully demonstrates compliance with article 52 – Conformity Assessment of Regulations (EU) 2017/745 and 2017/746. In this context, we draw your attention to the fact that certification must be carried out by a Notified Body and not by any other certifying entity.

 

Supported in the previous version of ISO 9001, the process approach and the PDCA management cycle are part of its matrix.

Activities to be implemented in order to comply with the requirements of this standard are the elaboration of a Quality Manual and the elaboration and implementation of procedures that ensure the necessary activities for the safe and effective placement of medical devices. Examples of these procedures are purchasing, production planning, production, storage and shipping, post-marketing procedures.

 

Predicted and mandatory activity, it is the internal audit that will monitor the effective implementation of the foreseen procedures.

The implementation of the requirements of this standard calls for all functions of the company and must be implemented by senior consultants able to read and understand the company. No less important is the auditor comprehensive knowledge of legal requirements and other associated documents such as the well-known Meddev’s.

We can help you in a efficient and effective implementation of the ISO 13485 standard.